Health conditions
(Source de données: WHO)
Inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
MedDRA version: 19.0Level: LLTClassification code 10068739Term: Chronic thromboembolic pulmonary hypertensionSystem Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Interventions (Source de données: WHO)
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: MACITENTAN
CAS Number: 441798-33-0
Current Sponsor code: ACT-064992
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Inclusion/Exclusion Criteria
(Source de données: WHO)
Inclusion criteria:
Subject with CTEPH having completed the double-blind (DB) AC-055E201 / MERIT-1 study as scheduled (i.e., who remained in the DB study up to Week 24).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 47
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 31
Exclusion criteria:
- Permanent discontinuation of DB study treatment due to an hepatic adverse event or liver aminotransferase abnormalities.
- Any known factor (e.g., drug or substance abuse) or disease (e.g., unstable psychiatric illness) that, in the opinion of the investigator, may interfere with treatment compliance or interpretation of the results, or that may influence the ability to comply with any of the study requirements.
-
Plus d’informations sur l’étude
Date d’enregistrement de l’étude
6 mai 2014
Intégration du premier participant
3 juil. 2014
Statut de recrutement
Not Recruiting
Titre scientifique
(Source de données: WHO)
Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - MERIT-2: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension(OL)
Type d’étude
(Source de données: WHO)
Interventional clinical trial of medicinal product
Conception de l’étude
(Source de données: WHO)
Controlled: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
Phase
(Source de données: WHO)
Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): yesTherapeutic confirmatory - (Phase III): noTherapeutic use (Phase IV): no
Points finaux primaires
(Source de données: WHO)
Main Objective: - To evaluate the long-term safety and tolerability of macitentan 10 mg in subjects with inoperable CTEPH
- To evaluate the long term effects of macitentan 10 mg on exercise capacity and functional class (FC).;Secondary Objective: Not Applicable;Primary end point(s): Evaluation of the long-term safety and tolerability:
- Treatment-emergent AEs up to 30 days after study drug
discontinuation.
- AEs leading to premature discontinuation of study drug.
- Treatment-emergent SAEs up to 30 days after study drug
discontinuation.
- Treatment-emergent marked laboratory abnormalities up to 30 days
after study drug discontinuation.
- Change in vital signs (blood pressure , heart rate) and body weight
from baseline to all assessed time points during the study;Timepoint(s) of evaluation of this end point: From baseline up to 30 days after study drug discontinuationpplicable
Points finaux secondaires
(Source de données: WHO)
Secondary end point(s): Change from baseline to each scheduled time point in exercise capacity,
as measured by the 6MWD;Timepoint(s) of evaluation of this end point: Baseline up to 30 months
Contact pour informations
(Source de données: WHO)
Actelion Pharmaceuticals Ltd.
Résultats de l’étude
(Source de données: WHO)
Résumé des résultats
Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
Lien vers les résultats dans le registre primaire
pas encore d’informations disponibles
Informations sur la disponibilité des données individuelles des participants
pas encore d’informations disponibles
Lieux de réalisation des études
Pays où sont réalisées les études
(Source de données: WHO)
Austria, Belgium, Bulgaria, Canada, Chile, China, Czech Republic, France, Germany, Hungary, Italy, Lithuania, Mexico, Netherlands, Poland, Russian Federation, South Africa, Switzerland, Thailand, Ukraine, United Kingdom, United States
Contact pour plus d’informations sur l’étude
Contact pour des informations générales
(Source de données: WHO)
Clinical Trial Disclosure Desk
Gewerbestrasse 16
Actelion Pharmaceuticals Ltd.
clinical-trials-disclosure@its.jnj.com
Contact pour des informations scientifiques
(Source de données: WHO)
Clinical Trial Disclosure Desk
Gewerbestrasse 16
Actelion Pharmaceuticals Ltd.
clinical-trials-disclosure@its.jnj.com
Plus de numéros d’identification d’étude
Secondary ID (Source de données: WHO)
AC-055E202
2013-003457-25-CZ
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